Real-time continuous glucose monitoring for young adults at risk of DKA
Official title: Assessment of the Impact of Real-time Continuous Glucose Monitoring on Glycaemic Control in High-risk Adolescents and Young Adults With Insulin-treated Diabetes
Run by Imperial College London · NCT04039763 · Data updated 2026-11-12
This project will try a Dexcom G6 real-time continuous glucose monitor to see if it helps 18-25-year-olds with insulin-treated diabetes who have poor blood sugar control or recent hospital admissions for high blood sugar.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 25 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | September 3, 2020 |
| Main results expected | June 30, 2022 |
| Study ends | June 30, 2022 |
| Registry record updated | June 24, 2022 |
| Trial ID | NCT04039763 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are 18-25-year-olds with insulin-treated diabetes for more than 12 months who are naive to RT-CGM and have HbA1c >75 mmol/mol (9%) or one or more DKA/uncontrolled hyperglycaemia admissions in the past year.
✕Probably not a fit
Patients with advanced kidney disease (eGFR <30 ml/min), pregnancy or breastfeeding, active malignancy investigations, severe visual or manual impairment, or who cannot use smartphone-linked devices may not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, controlled crossover pilot enrolls 18-25-year-olds with insulin-treated diabetes who have HbA1c >75 mmol/mol (9%) or a recent DKA/uncontrolled hyperglycaemia admission. Participants are randomized to six months of standard fingerprick self-monitoring or six months wearing the Dexcom G6 RT-CGM, then cross over for the second six months. Clinical outcomes (HbA1c, hospital admissions) are collected and participants may share Dexcom Clarity data with clinicians to guide treatment decisions. Semi-structured interviews with a diabetes specialist psychologist at baseline and after CGM use explore self-management barriers and device acceptability, and the pilot data will inform a larger powered trial.
Why it matters
Potential benefit: If successful, RT-CGM could lower HbA1c, reduce hospital admissions for high blood sugar, and improve daily self-management for high-risk young adults.
How similar studies have gone: Previous RT-CGM studies in adults and adolescents have shown improved glycaemic control and reduced hypoglycaemia, but evidence specifically targeting high-risk young adults with recent DKA is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adolescents and young adults aged 18-25 years * Insulin-treated diabetes \>12 months (on multiple daily injections or insulin pump therapy) * HbA1c \> 75 mmol/mol (9%) or 1 or more DKA admissions in the last 12 months or 1 or more admissions with uncontrolled blood glucose levels in the last 12 months. * Naïve to RT-CGM - except for short periods for use for diagnosis or monitoring purposes. * Use of prior flash glucose monitoring is permittable Exclusion Criteria: * Chronic kidney disease eGFR \<30ml/min * Pregnant or planning pregnancy * Breastfeeding * Have active malignancy or under investigation for malignancy * Severe visual impairment * Reduced manual dexterity * Unable to participate due to other factors, as assessed by the Chief Investigator
Where it's running
-
Imperial College Clinical Research Facility
London, United Kingdom Recruiting
Study contacts
- Principal investigator: Shivani Misra — Imperial College Healthcare NHS Trust
- Study coordinator: Shivani Misra
- Email: s.misra@nhs.net
- Phone: 02075946136
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.